Case Studies > Ditching admin tasks with the help of a supportive eQMS vendor

Ditching admin tasks with the help of a supportive eQMS vendor

Company Size
11-200
Region
  • America
Country
  • United States
Product
  • Neubie
  • Qualio
  • Qualio+
Tech Stack
  • eQMS
  • DocuSign
  • Dropbox
Implementation Scale
  • Enterprise-wide Deployment
Impact Metrics
  • Customer Satisfaction
  • Employee Satisfaction
  • Productivity Improvements
Technology Category
  • Functional Applications - Computerized Maintenance Management Systems (CMMS)
  • Functional Applications - Enterprise Asset Management Systems (EAM)
  • Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
  • Healthcare & Hospitals
Applicable Functions
  • Quality Assurance
Use Cases
  • Regulatory Compliance Monitoring
Services
  • System Integration
  • Training
About The Customer
NeuFit is an Austin-based manufacturer of Neubie, a neuromuscular electrical stimulation medical device. Neubie helps patients recover from neuromuscular damage and can treat conditions from plantar fasciitis to strokes and spinal cord injuries. NeuFit's team is small, with a Director of Operations & Quality Management, Ami Anderson, who is responsible for managing quality activities. The company faced significant challenges with their manual paper- and Dropbox-based system, which was cumbersome and time-consuming. This manual system led to inefficiencies and difficulties in managing quality and operations, especially during audits.
The Challenge
NeuFit relied on a manual paper- and Dropbox-based system to manage their quality activities. Documents required a cumbersome approach of downloading, editing, and passing to DocuSign for every edit. Key document updates were easily forgotten, and searching for information in multiple logs and filing cabinets became overwhelming. Director of Operations & Quality Management Ami Anderson spent 'every day, all day, and a lot of overtime thrown in' just completing quality admin tasks. Since her team of 2 were paid hourly and Ami was salaried, she would be first in line for after-hours work if things didn't get done. This excessive quality timesink meant the other half of her role – operations – didn’t get the same attention, causing issues in areas like supplier management. The issues with NeuFit’s manual system came to light when an FDA auditor arrived with a thumb drive, expecting to be able to load electronic quality documents and take them away with her. Her bag wasn’t large enough to hold the paper documents prepared by the NeuFit team.
The Solution
Ami homed in on three potential eQMS vendors for closer inspection. One option still required lots of manual change control, including downloading system documents for revision then re-uploading. The second option put Ami off with overly pushy sales tactics, which included putting down other eQMS vendors and overpromising functionality. During discussions with Qualio, Ami felt comfortable to discuss and explore her operational requirements without pressure. On top of that, the system itself met all of NeuFit’s needs. After NeuFit’s CEO Garrett Salpeter was impressed by Qualio too, sign-off was given to become Qualio customers. NeuFit took on additional Qualio+ support to accelerate their quality and compliance journey, and Ami was pleased by the entire onboarding and training experience.
Operational Impact
  • Qualio demolished the mountain of manual paperwork activity taking up Ami’s working week.
  • Moving the NeuFit quality management system into a digital platform unlocked oversight of areas invisible in a paper system. With Qualio’s reporting functionality, Ami could spot and fix a part defect with the potential to decrease patient comfort. Ami notes a clear uptick in customer reviews since implementing Qualio, driven by NeuFit’s ability to deliver a higher-quality product and service.
  • NeuFit’s pre-Qualio audit took 6 days, as the team scrambled to pinpoint and copy paper documents requested by their FDA auditor. Ami estimates that her audits now take half a day.
  • Besides unlocking greater visibility of quality events and issues, Ami and the NeuFit team can now close them out faster too. Where events took around 6 months to resolve pre-Qualio, they now take an average of 30-60 days.
  • Ami spent her entire working week just keeping NeuFit’s paper QMS afloat. Qualio has allowed her to reallocate this lost time to value-add activity, including continuous improvement and planning work for a second product launch. Instead of a 5-year estimate, Ami estimates they can now get their new device to market in just 2 years.
Quantitative Benefit
  • 400% ROI
  • Audits now take half a day instead of 6 days.
  • Quality events resolution time reduced from 6 months to 30-60 days.
  • Estimated time to market for new device reduced from 5 years to 2 years.

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